Search results with tag "Mutual recognition procedure"
VOLUME 2A Procedures for marketing authorisation CHAPTER …
ec.europa.euIt is possible to use the mutual recognition procedure more than once for subsequent ... States to raise objections based on potential serious risk to public health. In the case of such a repeat use procedure, the subsequent application for mutual ... original assessment report including the assessment of the updated dossier and
How to use the Defective Product Report to notify a ...
www.ema.europa.euHow to use the defective product report to notify a ... (NAPs) and Mutual Recognition Procedure/ Decentralised Procedure (MRP/DCP) are required to be sent to the relevan t National Competed Authority. 3. Product details . This section captures details of produc t (s) and batch (es) affected by the issue being reported.
Questions & Answers for applicants, marketing ...
www.ema.europa.eu• Consultation procedure for ancillary medicinal substances that are integral part of medical devices. This “questions and answers” document is being updated continuously and will be marked by “New” or ... of a DDC on a Mutual Recognition Procedure submitted on or after the 26 May 2021? Rev.